Matrices and methods for storage and stabilization of biological samples comprising viral rna

Abstract

Matrices and methods of stabilizing and storing biological samples containing nucleic acids are provided. The present application in particular provides systems and methods for stabilizing RNA and especially viral RNA in raw samples, where the stabilization and storage occur before additional processing, isolation, and analytical steps have taken place.

What is claimed is: 
     
         1 . A composition for stabilizing and storing viral RNA comprising:
 one or more metal chelators;   a hydroxyl radical scavenger;   a singlet oxygen quencher;   an RNase inhibitor; and   a cell separation reagent.   
     
     
         2 . The composition of  claim 1 , wherein the composition comprises two metal chelators. 
     
     
         3 . The composition of  claim 2 , wherein the two metal chelators comprise citric acid and an aminocarboxylate. 
     
     
         4 . The composition of  claim 1 , wherein the hydroxyl radical scavenger comprises mannitol. 
     
     
         5 . The composition of  claim 1 , wherein the singlet oxygen quencher comprises cysteine. 
     
     
         6 . The composition of  claim 1 , wherein the RNase inhibitor comprises ATA. 
     
     
         7 . The composition of  claim 1 , wherein the cell separation reagent comprises a polyethylene glycol. 
     
     
         8 . The composition of  claim 1 , wherein the composition stabilizes and stores viral RNA for at least five days. 
     
     
         9 . The composition of  claim 1 , wherein the composition stabilizes and stores viral RNA at a temperature between about 20° C. and about 60° C. 
     
     
         10 . The composition of  claim 1 , wherein the viral RNA is provided as part of a sample of whole blood or blood plasma. 
     
     
         11 . The composition of  claim 10 , wherein the viral RNA is stored on a paper carrier as dried blood spots (DBS) or dried plasma spots (DPS). 
     
     
         12 . A kit for stabilizing and storing viral RNA comprising:
 a composition comprising one or more metal chelators, a hydroxyl radical scavenger, a singled oxygen quencher, an RNase inhibitor, and a cell separation reagent;   one or more carriers; and   one or more closures;   wherein the composition is combined with a sample comprising viral RNA, held in the one or more carriers, and sealed by the one or more closures; and   wherein the composition stabilizes viral RNA for at least five days, and wherein the composition stabilizes viral RNA at an ambient temperature.   
     
     
         13 . The kit of  claim 12 , wherein the one or more carriers comprises one or more vials, one or more wells, paper, and/or a cotton swab. 
     
     
         14 . The kit of  claim 13 , further comprising an additional container for housing the composition and sample held in the one or more carriers and sealed by the one or more closures. 
     
     
         15 . The kit of  claim 14  wherein the additional container comprises a box and/or an envelope. 
     
     
         16 . The kit of  claim 15 , further comprising a pre-addressed mailing label. 
     
     
         17 . A method of using a kit for stabilizing and storing viral RNA comprising:
 providing a composition comprising one or more metal chelators, a hydroxyl radical scavenger, a singled oxygen quencher, an RNase inhibitor, and a cell separation reagent, wherein the composition stabilizes viral RNA for at least five days, and wherein the composition stabilizes viral RNA at an ambient temperature;   collecting one or more raw samples;   mixing the one or more raw samples with the composition in one or more carriers; and   sealing the mixture in the carrier with closures.   
     
     
         18 . The method of  claim 17 , further comprising the step of placing the sealed mixture in an additional container for housing the one or more carriers. 
     
     
         19 . The method of  claim 18 , further comprising the step of adding protective materials to the additional container, wherein the protective materials comprise protective foam, packing peanuts, and/or shredded paper filler 
     
     
         20 . The method of  claim 19 , further comprising the step of applying a pre-addressed mailing label to the additional container.